Vascular wound closure device and method

ABSTRACT

A method and apparatus for closing a vascular wound includes an apparatus that can be threaded over a guidewire into place at or adjacent the wound. The apparatus includes a chamber that encloses a hemostatic material therein. When the apparatus is positioned adjacent the wound as desired, the hemostatic material is deployed from the chamber. Blood contacts the hemostatic material, and blood clotting preferably is facilitated by a hemostatic agent within the material. Thus, the vascular puncture wound is sealed by blood clot formation.

RELATED APPLICATIONS

This application claims priority to U.S. Application Ser. No.60/495,424, which was filed Aug. 14, 2003, and also claims priority toU.S. Application Ser. No. 60/547,154, which was filed on Feb. 23, 2004.The entirety of each of these applications is hereby incorporated byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a system that facilitatesclosure of openings in blood vessels. More specifically, the presentinvention delivers a material adjacent a vessel.

2. Description of the Related Art

In many medical procedures, it is necessary to locate an opening intissue so that some form of treatment, diagnosis or revision, can beapplied to that opening. For example, in order to perform transluminalballoon angioplasty, an opening must be created in an artery in order toinsert a balloon. This opening must later be closed.

Transluminal balloon angioplasty is used in the treatment of peripheralvascular disease to increase or restore blood flow through asignificantly narrowed artery in a limb; it is also used in thetreatment of blockage of the coronary arteries. In fact, coronaryangioplasty has emerged as a major viable alternative to bypass surgeryfor revascularization of stenotic and occluded coronary arteries. Unlikebypass surgery, angioplasty does not require general anesthesia, openingof the chest wall, use of a heart-lung machine, or transfusion of blood.Angioplasty is not only less invasive and less traumatic to the patient,but is also less expensive because of the shorter hospital stay andshorter recovery time.

Transluminal balloon angioplasty is performed by first inserting ahollow needle through the skin and surrounding tissues and into thepatient's femoral artery. A guidewire is advanced through the hollowneedle and into the artery, then along the patient's vasculature towardthe site of the blocked blood vessel or valve to be treated. X-rayimaging is used to help guide the guidewire through the vascular systemand into position adjacent the stenosis to be treated. A ballooncatheter is then threaded over the guidewire and advanced until thedeflated balloon is within the stenosis. The balloon is then repeatedlyinflated to widen the narrowed blood vessel. After the procedure iscomplete, the catheter and guidewire are withdrawn from the bloodvessels and the patient.

After the catheter used during angioplasty is removed, the puncturewound in the femoral artery must be closed and the bleeding through thepuncture site in the artery stopped. Often, ice packs and/or pressureare applied to the area surrounding the wound for a period lasting up toseveral hours in an attempt to stop the bleeding. There exists, however,a significant chance that the wound will reopen and begin bleeding againwhen the patient moves. Another possible complication is the developmentof a false aneurysm, which increases the risks of both infection andreopening.

Efforts have been made to close the puncture wound using staples, clips,collagen plugs, and sutures. These efforts, and the devices incidentthereto, tend to be cumbersome and achieve only limited success.

Other wounds in the vasculature of a patient can also be difficult tolocate, access and close. Thus, a device and method to facilitatelocating and closing such wounds in the vasculature of a patient wouldbe beneficial. A device having the ability to consistently and reliablylocate, isolate and close the puncture wound would eliminate theprolonged bleeding currently associated with such wounds.

SUMMARY OF THE INVENTION

Accordingly, there is a need in the art for a device and method forprecisely locating a blood vessel wound and sealing the wound.

In accordance with one embodiment, an apparatus is provided forsubcutaneously delivering a material. The apparatus comprises anelongate delivery tube having a chamber configured to accommodate amaterial therewithin, an elongate pusher member having a distal portionconfigured to slidably extend through at least a portion of the deliverytube so as to push at least a portion of the material out of thedelivery tube, and a flexible locking member configured to fit at leastpartially around the pusher member and adapted to expand in a transversedirection when subjected to generally longitudinal compression. Theflexible locking member is disposed adjacent the pusher member so thatwhen the locking member is subjected to generally longitudinalcompression, the locking member expands transversely to engage thepusher member to increase friction between the pusher member and thelocking member.

In accordance with another embodiment, the pusher member has at leastone protuberance. The flexible locking member is disposed adjacent theprotuberance so that when the locking member is subjected tolongitudinal compression, the locking member expands transversely toengage the pusher member protuberance so that the pusher member isrestrained from moving relative to the locking member.

In accordance with yet another embodiment, the present inventiondescribes an assembly for closing a vascular wound. The assemblyincludes a delivery tube configured to accommodate a hemostatic materialtherewithin, an apparatus configured to position a distal end of thedelivery tube adjacent the vascular wound, a pusher member having adistal portion configured to fit at least partially through the proximalend of the delivery tube, and an adjustable stopper disposed about asurface of the pusher member. A portion of the pusher member has adiameter larger than the diameter of at least a portion of the deliverytube. The adjustable stopper is configured to engage the surface of thepusher member and to selectively move proximally or distally along thesurface of the pusher member to adjustably couple the apparatus and thedelivery tube.

In accordance with yet another embodiment a surgical method is providedcomprising accessing a subcutaneous blood vessel by forming a puncturethrough a wall of the blood vessel, advancing at least one surgicalimplement through the blood vessel puncture, and closing the puncture. Amajor surgical implement of the at least one surgical implement has adiameter advanced through the puncture that is greater than or equal toa diameter advanced through the puncture of any other of the at leastone surgical implement. Closing the puncture comprises providing avessel wound closure device comprising a catheter, a hemostatic materialdisposed on the catheter, and a pusher member configured to push thehemostatic material distally over the catheter. The catheter has adiameter greater than the diameter advanced through the puncture of themajor surgical implement. As such, the catheter engages wound edges ofthe puncture in a manner to substantially plug the puncture and preventhemostatic material from passing between the catheter and the wound edgeand into the blood vessel.

For purposes of summarizing the preferred embodiments and the advantagesachieved over the prior art, certain embodiments and advantages havebeen described herein above. Of course, it is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The embodiments discussed above and other embodiments will becomereadily apparent to those skilled in the art from the following detaileddescription of the preferred embodiments having reference to theattached figures, the invention not being limited to any particularpreferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of a vascular closure apparatusshown assembled and ready for use.

FIG. 2 is a side view of a distal portion of the apparatus of FIG. 1.

FIG. 3 is a side view of a push member having features in accordancewith the present invention.

FIG. 4 shows the apparatus of FIG. 1 advanced over a guidewire into ablood vessel of a patient.

FIG. 5 shows the arrangement of FIG. 4 with the retractor arms open anda suction tool in use.

FIG. 6 shows the arrangement of FIG. 5, wherein a hemostatic sponge hasbeen advanced into contact with the blood vessel wall.

FIG. 7 shows the arrangement of FIG. 6, with the retractor arms removed.

FIG. 8 shows the arrangement of FIG. 7 with the catheter and guidewireremoved.

FIG. 9 shows the arrangement of FIG. 8, wherein a flowable adhesive isbeing delivered to the sponge.

FIG. 10 shows the arrangement of FIG. 8, wherein the push member isbeing removed from the patient.

FIG. 11 shows a sealed puncture wound after treatment with an embodimentof the device and method.

FIG. 12 shows another embodiment of a vascular wound closure apparatus.

FIG. 13 shows a side view of a catheter for use according to theembodiment illustrated in FIG. 12.

FIG. 14 shows a retractor portion of the apparatus of FIG. 12 with theretractor arms in an open position.

FIG. 15 shows a side plan view of one of the retractor arms illustratedin FIG. 14.

FIG. 16 shows the catheter of FIG. 13 disposed in the retractor arm ofFIG. 15.

FIG. 17 shows a partially cutaway view of another embodiment of avascular wound closure apparatus.

FIG. 18 shows a side view of a catheter according to the embodimentillustrated in FIG. 17.

FIG. 19 shows a partially cutaway view of a pusher member according tothe embodiment illustrated in FIG. 17.

FIG. 20 shows a partially cutaway view of a delivery tube according tothe embodiment illustrated in FIG. 17.

FIG. 21 shows a cross section of the delivery tube of FIG. 20 takenalong line 21-21.

FIG. 22 shows a wall portion of the delivery tube of FIG. 20 having adetent catch coupling portion.

FIG. 23 shows the apparatus of FIG. 12 during use.

FIG. 24 shows a wall portion of another embodiment of a delivery tubehaving a j-lock coupling portion.

FIG. 25 shows another embodiment of a vascular wound closure apparatus.

FIG. 26 shows a partially cutaway side view of a catheter according tothe embodiment illustrated in FIG. 25.

FIG. 27 shows a partially cutaway cross-sectional view of a pushermember according to the embodiment illustrated in FIG. 25.

FIG. 28 shows a partially cutaway view of a delivery tube according tothe embodiment illustrated in FIG. 25.

FIG. 29 shows another embodiment of a vascular wound closure apparatus.

FIG. 30 shows a partially cutaway side view of a catheter according tothe embodiment illustrated in FIG. 29.

FIG. 31 shows a partially cutaway cross-sectional view of a pushermember according to the embodiment illustrated in FIG. 29.

FIG. 32 a shows a side view of a handle support for use in connectionwith the pusher member of FIG. 31.

FIG. 32 b shows a top view of the handle support of FIG. 32 a.

FIG. 33 shows a top view of the handle for use in connection with thepusher member of FIG. 31.

FIG. 34 shows a top view of the coupling member for use in connectionwith the pusher member of FIG. 31.

FIG. 35 shows a partially cutaway view of a delivery tube according tothe embodiment illustrated in FIG. 29.

FIG. 36 shows the delivery tube of FIG. 35 separated into two halves.

FIG. 37 is a side view of a fully-assembled vascular wound closuredevice having features in accordance with the embodiment illustrated inFIG. 29.

FIG. 38 shows the apparatus of FIG. 37 with the catheter, pusher memberand delivery tube uncoupled from one another.

FIG. 39 shows the apparatus of FIG. 37 deploying a hemostatic agent.

FIG. 40 is a side view of another embodiment of a vascular wound closureapparatus.

FIG. 41 is a cross sectional view of the apparatus of FIG. 40.

FIG. 42 a is a close up view of a portion of the apparatus of FIG. 41.

FIG. 42 b is a close up view of another portion of the apparatus of FIG.41.

FIG. 43 shows a portion of the apparatus of FIG. 41 in position adjacenta vascular wound.

FIG. 44 shows a delivery tube portion of the apparatus of FIG. 41separated into halves.

FIG. 45 shows a pusher member of the apparatus of FIG. 41.

FIG. 46 is a close up view showing a distal end of the pusher member ofFIG. 44 fit into a proximal end of the delivery tube of FIG. 44.

FIG. 47 shows a catheter portion of the apparatus of FIG. 41.

FIG. 48 is a close up view showing the catheter of FIG. 47 attached to aproximal end of the pusher member of FIG. 45.

FIG. 49 is a perspective view of a collar portion of the apparatus ofFIG. 41.

FIG. 50 shows a portion of the apparatus of FIG. 41 being advancedtoward a tissue wound.

FIG. 51 shows the arrangement of FIG. 50 with the apparatus in positionadjacent the wound and deploying a hemostatic agent.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present embodiments are especially useful for closing vascularpuncture wounds that are difficult to access and/or visualize. It isdifficult to directly and accurately modify a wound in a blood vessel inorder to close such wounds. Additionally, there are pitfalls associatedwith directly modifying the blood vessel. For example, since theclinician cannot see the wound, it is difficult to correctly placeclosure media such as sutures, staples, or clips. Incorrect placement ofsuch closure media likely results in inadequate closure; the puncturewound remains open, perhaps without the clinician being aware.Additionally, incorrect placement of closure media may cause permanentdamage to the vessel, including tearing and additional puncture wounds.Further, if closure media extends through the wound and into the bloodflow, this media can increase the likelihood of thrombus formation orcould introduce potentially toxic substances into the bloodstream. Ofcourse, closure media inadvertently released into the bloodstream couldlead to serious blood vessel blockage complications.

With reference to FIG. 1, a vascular wound closure assembly 30 includesan elongate catheter 32 having a distal end 34 and a proximal end 36 ofthe catheter 32. A distal opening 38 is formed through the distal end 34of the catheter 32 and opens along a longitudinal axis of the catheter32. The catheter 32 includes a tapered tip 40 at the distal end 34. Anelongate main body 42 of the catheter 32 is disposed proximal thetapered tip 40. Preferably the main body 42 has a substantially uniformdiameter along its length. A lumen 44 extends longitudinally within thecatheter 32 from the distal opening 38 to the proximal end 36.

A connector portion 46 is provided on the proximal end 36. The connectorportion 46 includes a main lumen 48 and a secondary lumen 50. The mainlumen 48 extends along the longitudinal axis of the catheter 32 and iscoextensive with the catheter lumen 44. The secondary lumen 50 extendsoutwardly from the main lumen 48, but communicates with the main lumen48 and the catheter lumen 44. A proximal opening 52 is provided at theproximal end of the main lumen 48 and, like the distal opening 38, opensalong the longitudinal axis. A secondary opening 54 opens into thesecondary lumen 50.

The distal and proximal openings 38, 52 are sized and adapted toaccommodate a guidewire 58 such as the guidewire used in angioplasty andother vascular surgeries. As such, the guidewire 58 can be threadedthrough the catheter 32 and the catheter can be advanced over theguidewire 58.

Holes 60 are formed through a side wall of the catheter 32 near thedistal end 34 of the catheter 32. Preferably, at least two holes 60 areprovided. All of the holes 60 preferably are disposed substantially thesame distance from the distal end 34 of the catheter 32. Preferably, araised portion 62 of the catheter 32 is provided in the region aroundthe holes 60, which region is proximal of the tip 40 and distal of themain body 42. At the raised portion 62, the catheter 32 has an outerdiameter that is slightly larger than the outer diameter throughout thecatheter main body 42.

With continued reference to FIG. 1, a vacuum or other source of suction64 is provided and communicates, through tubing 66, with the secondarylumen 50 of the catheter connector portion 46. Thus, a vacuum is drawnthrough the catheter lumen 44. Preferably, the distal and proximalopenings 38, 52, which accommodate the guidewire 58, are sized so thatthe guidewire 58 substantially plugs the openings; thus, the vacuum isdrawn through the holes 60. A viewing port 68 is arranged between thesource of suction 64 and the catheter 32. The viewing port 68 isconfigured to allow a clinician to view the material that is drawn bysuction through the holes 60 and through the catheter lumen 44. Theviewing port 68 will be discussed in more detail below.

With reference to FIGS. 1 and 2, a retractor 70 preferably is mounted onthe catheter 32. The retractor 70 includes opposing elongate retractorarms 72 that are aligned longitudinally on the catheter 32. A retractorbody 74 is configured to selectively open and close the retractor arms72 when operated by a clinician. The elongate retractor arms 72 of theretractor 70 are positioned on the catheter 32 so that distal ends 76 ofthe arms are positioned proximal of the catheter holes 60 a distancethat is at least the same as the width of an artery wall, preferably atleast about 0.5 to 2 millimeters.

It is to be understood that the present device can include structurethat is somewhat different than the particular structure shown in FIGS.1 and 2. For example, other catheter and retractor structures canappropriately be used. For example, some acceptable catheter andretractor embodiments are presented in U.S. application Ser. No.09/325,982, filed on Jun. 4, 1999, now U.S. Pat. No. 6,287,322, which ishereby incorporated by reference in it entirety.

With reference again to FIG. 1, a hemostatic member 80 is arranged onthe catheter 32 proximal of the retractor 70. As will be discussed inmore detail below, the hemostatic member comprises a material that ismade of or includes a hemostatic agent. The hemostatic agent is adaptedto aid blood clotting. In one embodiment, the hemostatic member 80comprises a sponge or sponge-like material. In this description, theterm sponge is intended to be a broad term that is used in accordancewith its ordinary meaning and refers to, without limitation, a materialthat is at least partially porous and is adapted to allow at least someblood to flow into and within the material so as to soak the materialwith blood. For example, a sponge may include a natural or artificialsponge, a woven or non-woven cloth, a fibrous puff or the like.Additionally, a sponge may comprise a material that soaks up at least aportion of blood that may come in contact with the material, or maycomprise a material that doesn't soak up blood.

For purposes of this description, the hemostatic member 80 is referredto as the sponge 80. However, it is to be understood that use of theterm “sponge” does not limit the scope of materials that can be used asthe hemostatic member. In fact, any material that aids or facilitatesblood clotting can be used as the hemostatic member.

Throughout this description, the term hemostatic agent is used as abroad term in its ordinary sense and refers to, without limitation, anagent that promotes blood clotting. Such an agent may take many forms,including liquid, powder, beads, etc. and can include or be combinedwith a substrate or carrier. The term hemostatic material is also usedin this description as a broad term used in its ordinary sense. Itrefers to, without limitation, any material having properties thatpromote blood clotting. Thus, hemostatic material can include ahemostatic agent taken alone or in combination with a substrate orcarrier that is formed separately from the agent. The term hemostaticmaterial includes hemostatic sponges.

Preferably, the sponge 80 extends circumferentially around the cathetermain body 42, and is arranged so that it can be slid longitudinallyalong the catheter 32. Most preferably, the catheter 32 extends througha passageway 82 through the sponge 80. The passageway 82 is formed asthe catheter 32 is forced through the sponge 80.

A push member 84 is also arranged on the catheter 32 proximal of thesponge 80. With reference also to FIG. 3, the push member 84 comprises abody portion 86 and a proximal handle portion 88. An elongate lumen 90is formed through the body portion 86. As shown in FIG. 1, the lumen 90preferably encircles the catheter 32 so as to allow the push member 84to slide relative to the catheter 32. A plurality of holes 92 are formedthrough the body portion 86 at a point near the distal end of the pushmember 84.

As will be discussed in more detail below in connection with FIG. 4, thevascular wound closure assembly 30 enables a clinician to preciselylocate a subcutaneous vascular wound “w”, access the wound w, anddeliver the hemostatic sponge 80 to the wound site. The hemostaticsponge 80 includes a hemostatic agent that helps facilitate closure ofthe wound w.

In order to properly apply the hemostatic sponge 80, the vascularclosure assembly 30 first precisely locates and provides access to thevascular wound w. It is to be understood that the present method andapparatus can be used to close various vascular and other wounds. FIGS.1-11, and the accompanying discussion, present an example using anembodiment to close a puncture wound w in a patient's femoral artery 94.

With specific reference to FIGS. 1, 2, 4 and 5, in order to preciselylocate and provide access to a femoral artery puncture wound w, thecatheter 32 is first threaded over a guidewire 58 that has beenpreviously inserted into the patient's femoral artery 94 through thepuncture wound w. The lumen 44 is attached to the source of suction 64and the assembly 30 is advanced over the guidewire 58 through apatient's tissue 96 so that the distal tip 40 of the catheter 32 extendsthrough the vascular puncture wound w.

As the assembly 30 is advanced, the source of suction 64 draws bodilyfluids through the holes 60. The fluids pass through the viewing port68, which allows the clinician to identify the fluids being withdrawn.The viewing port 68 can have any suitable structure or location. Forexample, the viewing port can comprise clear tubing attached to thecatheter, a substantially transparent syringe that functions as both asource of suction and a viewing port, or a portion of the catheter thatis substantially transparent. Most preferably, the catheter 32 is formedof a transparent material so that the clinician becomes aware as soon asblood begins to be drawn through the catheter.

When the holes 60 pass the artery wall 98 and enter the blood vessel 94,as shown in FIG. 4, blood “b” begins to be drawn through the holes 60into the catheter 32 and is conducted past the viewing port 68. Thus,when blood b is observed in the viewing port 68, the clinician will knowthat the holes 60 have just passed into the puncture wound w and thatthe distal ends 76 of the retractor arms 72 are thus positioned adjacentthe outer wall 98 of the artery 94, preferably within about 2 mm of theartery wall 98. The retractor arms 72 are then separated as shown inFIG. 5, thus drawing surrounding tissue 96 away from the wound w andcreating a field 100 around the puncture wound w. The catheter 32remains disposed partially within the puncture wound w, effectivelyplugging the wound and preventing blood from flowing through the wound.The raised portion 62 flexes the edges of the wound w to enhance theseal between the catheter 32 and the puncture wound edges.

With continued reference to FIG. 5, a suction tool 102 can be used toclear away bodily fluids and other matter that may be within the field100 and to clean the wall 98 of the blood vessel 94 adjacent thepuncture wound w.

With reference next to FIG. 6, once the puncture wound w has beenprecisely located, the push member 84 is advanced distally along thecatheter 32, thus advancing the sponge 80 into contact with the vesselwall 98 so as to surround the puncture wound w. As mentioned above anddiscussed in more detail below, the sponge 80 comprises a hemostaticagent that will help accelerate blood clot formation at the wound site win order to help the wound heal faster.

Preferably, the sponge 80 is at least partially coated with an adhesiveso that the sponge will at least partially bond to the vessel wall 98.Alternatively, or in addition, flowable adhesive can be delivered intothe field around the puncture wound before the sponge is advanced intocontact with the vessel wall. Of course, the sponge can be deliveredwithout using any adhesive.

The sponge 80 preferably is mounted onto the catheter 32 so as tosubstantially encircle the catheter 32. Thus, since the tip 40 of thecatheter is disposed in the wound, the sponge 80 substantially surroundsthe wound w when the sponge is positioned adjacent the vessel wall 98.When the sponge 80 is in place adjacent the wound w, the retractor 70can be removed, as shown in FIG. 7. When the retractor 70 is removed,the surrounding body tissues 96 collapse around the sponge 80 and pushmember 84. The push member 84 holds the sponge 80 in position while bodytissue 96 surrounds the sponge 80 and while the adhesive cures.

With reference next to FIG. 8, with the push member 84 in place, thecatheter 32 and guidewire 58 can also be removed from the patient. Thepassage 82 through the sponge 80, which had been occupied by thecatheter 32, collapses onto itself so that it is substantially closed.The vessel wound w is no longer plugged by the catheter 32, and it isanticipated that blood b from the vessel 94 will flow into the sponge80, at least partially soaking the sponge 80. Although the retractor 70is removed prior to the catheter 32 in the above-discussed embodiment,it is to be understood that, in another embodiment, the catheter may beremoved prior to the retractor.

In still another embodiment, additional pressure can be applied to thepush member 84 in order to at least partially block blood flow throughthe blood vessel 94. In this manner, the clinician can control howquickly blood will flow through the wound w and into the sponge 80. Ofcourse, other methods and apparatus can be used to temporarily reduce orstop blood flow through the vessel.

In a preferred embodiment, the sponge 80 comprises a material made of,soaked in or otherwise treated with a hemostatic agent. The agent isspecially adapted to aid blood clotting. Thus, blood that flows into thesponge encounters the agent and will quickly become clotted, causingnatural sealing of the wound through blood clotting. Sponge-likehemostasis agents are available and can include products such asGelfoam™, Oxycell™ and Avitene™. Another material that can be used as asponge is chitosan. These and other appropriate sponges may beimpregnated with agents such as thrombin, a liquid clotting agent, tohelp accelerate blood clot formation and Hemadex™, which is availablefrom Medafor, Inc. Another material that may advantageously be used is acollagen Ultrafoam™ sponge marketed by C.R. Bard/Davol, Inc. TheUltrafoam™ sponge is made from Avitene™ collagen, a natural clottingagent, and does not require the addition of thrombin. This reducespreparation time and the risk that a patient will experience apotentially hazardous reaction to bovine thrombin. Other medicaments canalso be included in the sponge. For example, antibiotic medicines,anti-inflammatory drugs, healing aids, and the like can be impregnatedinto the sponge material.

In a particularly preferred embodiment, the hemostatic agent comprises astarch such as bioabsorbable microporous polysaccharide microspheres(e.g., TRAUMADEX™ marketed by Emergency Medical Products, Inc. ofWaukesha, Wis.). The microspheres have micro-replicated porous channels.The pore size of the microspheres facilitates water absorption andhyperconcentration of albumin, coagulation factors, and other proteinand cellular components of the blood. The microspheres also affectplatelet function and enhance fibrin formulation. In addition, themicrospheres are believed to accelerate the coagulation enzymaticreaction rate. When applied directly, with pressure, to an activelybleeding wound, the particles act as molecular sieves to extract fluidsfrom the blood. The controlled porosity of the particle excludesplatelets, red blood cells, and serum proteins larger than 25,000Daltons, which are then concentrated on the surface of the particles.This molecular exclusion property creates a high concentration ofplatelets, thrombin, fibrinogen, and other proteins on the particlesurface, producing a gelling action. The gelled, compacted cells andconstituents accelerate the normal clotting cascade. The fibrin networkformed within this dense protein-cell matrix adheres tightly to thesurrounding tissue. The gelling process initiates within seconds, andthe resulting clot, while exceptionally tenacious, breaks down normallyalong with the microparticles. Such microporous polysaccharidemicrospheres, and additional hemostatic agents, are discussed in moredetail in Applicants' copending application entitled “DeployableMultifunctional Hemostatic Agent,” U.S. application Ser. No. 10/868,201,filed Jun. 14, 2004, the entirety of which is hereby incorporated byreference.

Any suitable hemostatic substrate can be employed as a support for thehemostatic agents of preferred embodiments. However, in a particularlypreferred embodiment the hemostatic substrate comprises chitosan.Chitosan is obtained from chitin, a biopolymer obtained principally fromshrimp and crab shell waste. Chitosan is the main derivative of chitin,and is the collective term applied to deacetylated chitins in variousstages of deacetylation and depolymerization. The chemical structure ofchitin and chitosan is similar to that of cellulose. The difference isthat instead of the hydroxyl group that is bonded at C-2 in eachD-glucose unit of cellulose, there is an acetylated amino group(—NHCOCH₃) at C-2 in each D-glucose unit in chitin and an amino group atC-2 in each D-glucose unit of chitosan.

Chitin and chitosan are both nontoxic, but chitosan is used more widelyin medical and pharmaceutical applications than chitin. Chitosanexhibits good biocompatibility and is biodegradable by chitosanase,papain, cellulase, and acid protease. Chitosan exhibitsanti-inflammatory and analgesic effects, and promotes hemostasis andwound healing. Chitosan has also been used as a hemostatic agent insurgical treatment and wound protection. The hemostatic effect ofchitosan has been described in U.S. Pat. No. 4,394,373.

A single hemostatic substrate or combination of hemostatic substrates ofdifferent forms and/or compositions can be employed in the devices ofpreferred embodiments. Different substrate forms can be preferred, forexample, fibrous puff, fleece, fabric, sheet, suture, or powder. Ahomogeneous mixture of different substrate-forming materials can beemployed, or composite substrates can be prepared from two or moredifferent formed substrates. A preferred composite comprises chitosanand collagen. Additional details concerning chitosan and other suitablesubstrates are discussed in more detail in Applicants' copendingapplication “Deployable Multifunctional Hemostatic Agent.”

The sponge-like substrate material preferably is soft and pliable andwill conform to the structure of the blood vessel, the wound and thefield around the blood vessel. Thus, the sponge-like material isspecially suited for use in the confined space surrounding a vascularpuncture. Additionally, the hemostatic sponge 80 will be held in placeby the tissue 96 surrounding the puncture wound w, which tissue 96collapses over the sponge 80 when tools such as the retractor 70 areremoved.

To further help hold the sponge 80 in place, flowable adhesive 106 froma source of adhesive 108 can be delivered through the lumen 90 of thepush member 84 and onto the sponge 80, as shown in FIG. 9. The adhesive106 flows through the open distal end of the push member 84 and alsothrough the holes 92 through the push member body portion 86. Uponcuring, the adhesive 106 can form a sealing layer around and within thesponge 80, thus confining the blood b to the sponge area. This helpsminimize bleeding and even further speeds clot formation. In oneembodiment, adhesive, when cured, is substantially non-porous, and thusconfines blood to a desired area. Adding adhesive 106 will alsofacilitate more complete closure of the passage through the sponge,which passage was vacated by the catheter 32. Further, the adhesive 106will help hold the sponge 80 in place relative to the puncture wound wand the surrounding tissue 96.

As discussed above, prior to being advanced into contact with the bloodvessel wall, the sponge 80 may be soaked in an adhesive or, morepreferably, coated with a layer of adhesive. In this manner, adhesivedistribution on the sponge can be controlled. By controllably applying acoating of adhesive around the outer surface of the sponge, the adhesivewill bond the sponge to the area surrounding the blood vessel wound w,including the vessel 94 itself, and also can form a perimeter seal ofthe sponge when the adhesive cures. The coating of adhesive can act as anon-porous or selectively-porous membrane confining the blood b to thesponge 80. It is to be understood that a coating of adhesive may be usedinstead of or in addition to applying additional adhesive 106 throughthe push member 84.

Various kinds of flowable adhesives may be acceptable for use with thesponge. For example, fibrin tissue sealants such as Tisseel®, which isavailable from Baxter Healthcare Corp., may be appropriate. Othercommercially available adhesives that may be appropriate includeBioglue™, available from Cryolife, Inc., and Floseal™, which isavailable from Fusion Medical Technologies. Various cyanoacrylateadhesives are currently commercially available and can be used with thisinvention. Of course, any product that is capable of sealing the spongeor at least retarding blood flow through or beyond the sponge would beacceptable. It is also to be understood that certain adhesives will notrequire that the field and/or the outer wall of the blood vessel becleared before the adhesive is injected.

Curing time and ease of use will vary depending on the adhesive used.For example, some adhesives cure to a malleable gel-like state within afew seconds, while others will cure directly to a hardened state in afew minutes. The time period for curing is chosen to allow the clinicianto advance the sponge into position adjacent the wound and in contactwith the artery, at which time the sponge will begin to be bonded to thevessel wall and substantially sealed by the adhesive. It should beappreciated that any acceptable adhesive having any acceptable curingtime may be used. In accordance with this description, an adhesive isconsidered to be cured when it is adhered to surrounding tissue, andwhen it does not spontaneously flow.

The push member 84 may be kept in place for any reasonable time periodin order to allow the adhesive 106 to cure. Also, multiple sponges canbe used, if desired. Preferably, however, the adhesive 106 will curesufficiently in about five minutes or less. Other tools, such as anultraviolet light source or a heat application device, may be used tohelp speed adhesive curing.

Once the sponge 80 is correctly placed, the push member 84 can beremoved. Removal of the push member 84 can be aided by a release rod 110which, as shown in FIG. 10, is advanced through the push member lumen 90and into contact with the sponge 80. The release rod 110 holds thesponge 80 in place as the push member 84 is withdrawn from the patient.Thus, the release rod 110 engages the sponge 80 so as to provide countertraction when the push member 84 is withdrawn. In this way, the pushmember 84 can be removed even if some adhesion occurs between the sponge80 and the push member 84. With reference next to FIG. 11, once therelease rod 110 is withdrawn, the patient's skin 112 is closed by anyappropriate closure media such as, for example, sutures 114. Thehemostatic sponge 80 is left in place. The body's natural blood clottingprocess will plug and repair the vascular wound w with the aid of thehemostatic sponge 80. Thus, healing will proceed without the danger offalse aneurysms, missed or faulty wound closure, or the like.

In the embodiment illustrated in FIGS. 1-9, the catheter comprises asingle-lumen catheter. In another embodiment (not shown), the elongatecatheter has a first lumen comprising a tube that extends from thedistal end opening to the proximal end opening and slidinglyaccommodates the guidewire therewithin. The outer wall of the catheterdefines a second lumen that concentrically surrounds the first lumen.The holes through the outer wall of the catheter open into the secondlumen. Additionally, an access lumen communicates with the second lumen.In this embodiment, the distal and proximal openings, which accommodatethe guidewire, do not communicate with the second lumen, which lumencommunicates with the source of suction through the access lumen.Accordingly, in this embodiment, there may be less of a chance that bodyfluids will be drawn into the catheter through the distal and proximalguidewire openings than in an embodiment employing a single lumen.However, the single-lumen catheter can be less expensive to manufactureand can be expected to have a smaller diameter than the dual-lumencatheter.

With reference next to FIGS. 12-16, another embodiment of a vascularwound closure apparatus is presented. The apparatus includes a retractor200 and an elongate catheter 250.

With particular reference to FIG. 13, the catheter 250 has a proximalend 250 a and a distal end 250 b. A distal opening is formed through thedistal end of the catheter and opens along a longitudinal axis of thecatheter. A lumen 250 c is defined within the catheter. A tip 256 at thedistal end 250 b of the catheter 250 preferably is tapered. A connectorportion is provided on the proximal end 250 a, which connector portionpreferably includes a main lumen and a secondary lumen. The main lumenextends along the longitudinal axis of the catheter and is coextensivewith the catheter lumen 250 c. At least one indicator hole 258 is formedthrough a side wall of the catheter near the distal end. Preferably thecatheter 250 is generally straight and is sized between about 4-8F andmore preferably about 6F.

An outer surface 252 of the catheter 250 preferably has a generallycylindrical shape and includes a raised portion 254. In one preferredembodiment, the raised portion 254 defines a connection between twoseparate sections (not shown) of the catheter 250. In the illustratedembodiment, the raised portion 254 is cylindrical and includes a length254 a.

With continued reference to FIG. 13 a pusher member 260 preferably ismovably disposed about the outer surface 252 of the catheter. The pushermember 260 preferably is configured to slide over the catheter 250. Thepusher member 260 preferably has an inner lumen having a diametergreater than the raised portion 254 of the catheter 250 so that thepusher member 260 can slide over the raised portion 254.

With reference next to FIGS. 14-16, the retractor 200 preferably isconfigured to be mounted onto the catheter 250. In the illustratedembodiment, the retractor 200 preferably has two retractor arms 202movably connected to each other, each having a length 204 from aproximal end 206 to a distal end 208. The retractor arms 202 preferablyare capable of being moved between an open position (see FIG. 14) and aclosed position (see FIG. 12). When in the closed position, asillustrated in FIG. 12, the retractor arms 202 preferably enclose atleast a portion of the catheter 250. Although the illustrated embodimentof the retractor 200 shows only two retractor arms 202, it should beunderstood that the retractor 200 can have more than two retractor arms202.

With continued reference to FIGS. 14 and 15, each of the retractor arms202 preferably defines an inner surface 210 generally facing the innersurface 210 of the other arm 202. Each inner surface 210 defines edges212 that preferably extend along the length 204 of the arms 202. Theinner surface 210 also preferably defines a cavity or channel 220extending between the edges 212. The channel 220 preferably extends thelength of the retractor arms 202. When the retractor arms 202 are in theclosed position, as shown in FIG. 12, the channels 220 on the retractorarms 202 preferably combine to define a canal 221 extending the length204 of the arms 202.

With reference to FIGS. 14-15, the channel 220 preferably comprises aproximal portion 222 disposed at the proximal end 206 of the retractorarms 202. In a preferred embodiment, the proximal portion 222 has agenerally curved shape configured to removably receive and substantiallycontact and hold at least a portion of the catheter 250 in a fixedposition when the retractor arms 202 are in the closed position. Theproximal portion 222 also has a depth 222 a generally orthogonal to thelength 204 of the retractor arms 202. For example, the proximal portion222 can have a semi-circular cross-section with a radius 222 a about thesame as that of an outer surface 252 of the catheter 250. However, theproximal portion 222 can have any shape configured to substantiallycontact the catheter 250 when the retractor arms 202 are in the closedposition. Most preferably, the proximal portion 222 is sized andconfigured generally complementary to the catheter 250 so that theretractor 200 holds the catheter 250 generally snugly at the proximalportion 222.

With continued reference to FIGS. 15 and 16, the channel 220 preferablycomprises a receiver portion 224 adjacent the proximal portion 222. Thereceiver portion 224 preferably has a generally curved shape and has adepth 224 a generally orthogonal to the length 204 of the arms 202 thatis greater than the depth 222 a of the proximal portion 222.Accordingly, the receiver portion 224 defines an edge 224 b between thereceiver portion 224 and the proximal portion 222. The illustratedreceiver portion 224 has a semi-circular cross-section with a radius 224a that is greater than the radius 222 a of the proximal portion 222.Most preferably, the receiver portion 224 is generally complementary tothe catheter raised portion 254 so as to receive the raised portion 254therein.

The channel 220 also preferably comprises a contact portion 226 adjacentthe receiver portion 224. Similar to the proximal portion 222, thecontact portion 226 preferably is generally complementary to thecatheter outer surface 252 and is configured to removably receive, andto substantially contact and hold the catheter 250 when the retractorarms 202 are in the closed position. The contact portion 226 preferablyhas a depth 226 a generally orthogonal to the length 204 of theretractor arms 202. In one preferred embodiment, the depth 216 a issimilar to the depth 222 a of the proximal portion 222. For example, thecontact portion 226 can have a semi-circular cross-section with a radius226 a about the same as the radius 222 a of the proximal portion 222.The depth 226 a of the contact portion 226 is also preferably smallerthan the depth 224 a of the receiver portion 224, so that the receiverportion 224 defines an edge 224 c between the receiver portion 224 andthe contact portion 226.

With reference still to FIGS. 15 and 16, in the illustrated embodiment,the proximal portion 222 and contact portion 226 each are smaller thanthe receiver portion 224. Most preferably, the proximal portion 222 andcontact portion 226 are configured so that the catheter raised portion254 cannot slide through either portion 222, 226. Thus, when the raisedportion 254 is disposed in the receiver portion 224 as shown in FIG. 16,the raised portion is constrained from moving proximally or distally. Assuch, the entire catheter 250 is longitudinally locked in place relativeto the retractor 200 when the retractor arms 202 are closed about thecatheter as shown in the FIG. 12.

The channel 220 further preferably comprises a compartment portion orchamber 228 adjacent the contact portion 226. The chamber 228 preferablyhas a generally curved shape and a depth 228 a generally orthogonal tothe length 204 of the retractor arms 202 greater than the depth 226 a ofthe contact portion 226. For example, the chamber 228 can have asemi-circular cross-section with a radius 228 a greater than the radius226 a. Further, the contact portion 226 defines an edge 226 b betweenthe contact portion 226 and the chamber 228. The chamber 228 isconfigured to receive a portion of the catheter 250 therein and todefine a space 228 b between the catheter 250 and the retractor arms202. When the retractor arms 202 are in the closed position, the space228 b extends generally about the entire circumference of the catheter250. The space 228 b is configured to receive and accommodate ahemostatic material 270 therein so that it surrounds at least a portionof the outer surface 252 of the catheter 250. The hemostatic material270 is further described below.

A distal portion 230 of the channel is defined adjacent the chamber 228and has a depth 230 a generally orthogonal to the length 204 of theretractor arms 202 smaller than the depth 228 a of the chamber 228. Thedistal portion 230 preferably is generally complementary to the catheterouter surface 252 so as to substantially contact and hold the catheter250 when the retractor arms 202 are in the closed position. For example,the distal portion 230 can have a semi-circular cross-section with aradius 230 a. In one preferred embodiment, the radius 230 a is about thesame as the radius 226 a of the contact portion 226 and/or the radius222 a of the proximal portion 222. A generally smooth transition section230 b preferably connects the chamber portion 228 and the distal portion230.

With reference again to FIGS. 12-16, in practice, the hemostaticmaterial 270 is preferably disposed about the outer surface 252 of thecatheter 250 at a location between the raised portion 254 and thecatheter holes 258. The catheter 250 is placed in the channel 220, whilethe arms 202 are in the open position, so that the raised portion 254 isdisposed in the receiver portion 224 and the hemostatic material 270 ishoused in the chamber 228. Preferably, the catheter 250 and retractor200 are configured so that, when assembled, the distance between thedistal end 208 of the retractor arms 202 and the indicator holes 258 isat least the same as the width of an artery wall. Preferably, saiddistance is at least about 0.5 to 2 millimeters.

When the retractor arms 202 are moved into the closed position with theraised portion 254 disposed in the receiver portion 224, the catheter250 is longitudinally locked relative to the retractor 200. Thus, thecatheter 250 and retractor 200 will move together even if longitudinalforces are exerted upon one or the other structure. In use, theapparatus is advanced into the patient so that the catheter 250 isadvanced into the wound “w” as discussed above in connection with theembodiment discussed in connection with FIGS. 1-4. When blood “b” isobserved in a viewing port (not shown) connected to the catheter 250,the retractor arms 202 are then preferably moved into the open position.The pusher member 260 is then advanced toward the distal end 250 b ofthe catheter 250 to engage and advance the hemostatic material 270 intocontact with the wound w.

In the embodiment illustrated in FIGS. 12-16, the hemostatic material270 preferably comprises a malleable, fibrous material. For example,preferably the substrate comprises a puff—a fibrous, cotton-likematerial that can be manipulated into a suitable shape or size so as toaccommodate a particular wound configuration. Most preferably, thehemostatic material 270 comprises a puff prepared from chitosan fibersand infused with microporous polysaccharide microspheres. Applicants'copending application “Deployable Multifunctional Hemostatic Agent”discusses such a hemostatic puff and methods of depositing microporouspolysaccharide microspheres thereon. Other fibrous substrates andhemostatic agents may also be employed in other embodiments.

In still other embodiments, the hemostatic material 270 can be infusedwith any number of medications associated with the treatment of wounds.For example, antibiotic and anti-inflammatory medications may be furtherinfused or deposited on a substrate.

It is further to be understood that, in accordance with furtherembodiment, the raised portion 270 can have various configurations. Forexample, the raised portion may not extend circumferentially about thecatheter 250, and a plurality of raised portions may be employed.Preferably, the receiver portion of the retractor 200 is shapedcomplementary to the raised portion. Additionally, the inner lumen ofthe pusher member 260 may have a cross sectional shape configured to fitover the raised portion, and may in some embodiments be non-circular.

With reference next to FIGS. 17-23, another embodiment of a vascularwound closure assembly 300 comprises a catheter 310 having a proximalend 312 and a distal end 314, and defining a lumen (not shown)therebetween. A pusher member 330 having a proximal end 332 and a distalend 334 is slidably disposed on the catheter 310. A delivery tube 350having a proximal end 352 and a distal end 354 is slidably disposed onthe catheter 310 and is positioned distal of the pusher member 330. Theclosure assembly 300 preferably is made of a polymeric material, such aspolypropylene. Preferably, the assembly 300 is also made ofhypoallergenic materials.

With particular reference to FIG. 18, the catheter 310 preferablycomprises a stop member 316 disposed in a fixed position about thecatheter surface 310 a. The distal end 314 preferably is tapered, andcatheter holes 318 are formed through a side of the catheter 310proximal of the distal end 314. In one embodiment, the catheter 310preferably comprises a secondary branch 319 disposed at the proximal end312, and having a secondary lumen (not shown) connected to the lumen ofthe catheter 310. The secondary branch 319 preferably is configured tooperatively connect to a variety of devices used in the closure ofvascular wounds, such as a suction device. For example, in oneembodiment, a syringe can be connected to the secondary branch 319 topull a vacuum through the catheter 310.

A coupling member 320 preferably is movably disposed about the catheter310 and is configured to mechanically couple to the stop member 316. Inthe illustrated embodiment, the stop member 316 is threaded on its outersurface and the coupling member 320 is threaded on its inner surface sothat the respective threads are engageable so that the coupling member320 and catheter 310, when engaged, do not move longitudinally relativeto one another. As such, the member 320 and catheter 310 are releasablycoupled to one another. In other embodiments, other suitable mechanicalcoupling mechanisms can be used. For example, a detent and catchmechanism or a j-lock mechanism can also be acceptably employed.

In this description, the term releasably coupled is a broad term used inits ordinary sense and referring to, without limitation, to membersbeing attached or affixed to one another in a manner so that they can bedecoupled from one another. For example, without limitation, members canbe coupled with threads, a detent mechanism, a conformed yet breakablebridge, such as flashing from injection-molding, an adhesive, or thelike.

With particular reference next to FIG. 19, the pusher member 330preferably comprises a generally cylindrical central portion 336, agenerally conical transition portion 337 and a generally cylindricaldistal portion 338. The diameter of the central portion 336 preferablyis larger than the diameter of the distal portion 338. The pusher member330 preferably defines a canal 330 a that extends from the proximal end332 to the distal end 334 and which is preferably configured to slidablyreceive the catheter 310, therethrough. For example, the canal 330 a canhave a circular cross-section with a diameter larger than the diameterof the catheter surface 310 a. However, the canal 330 a is not largeenough to fit over the catheter stop member 316. As such, the pushermember 330 cannot be moved proximally over the catheter 310 beyond thestop member 316.

The pusher member 330 preferably comprises a handle 340 near theproximal end 332. It is to be understood that the pusher member 330 cancomprise more than one handle 340.

A proximal coupling member 342 is disposed at the proximal end 332. Inthe illustrated embodiment, the proximal coupling member 342 comprisesthreads on its outer surface sized and configured to engage the threadsof the coupling member 320. As shown in FIG. 27, the catheter couplingmember 320 is configured to engage both the stop member 316 and thepusher member proximal coupling member 342 so as to selectively hold thepusher 330 longitudinally fixed relative to the catheter 310.

A distal coupling member 344 is disposed proximal the transition portion337. In the illustrated embodiment, the distal coupling member 344comprises a generally hemispherical raised portion.

With particular reference next to FIGS. 20-21, the delivery tube 350preferably has a body 350 a with a conical outer surface 350 b having agenerally decreasing diameter 350 c between a top edge 357 at theproximal end 352 and the distal end 354. A wall 350 e of the deliverytube 350 has a thickness “t”. The delivery tube wall 350 e preferablydefines a chamber 350 d extending from the proximal end 352 to thedistal end 354 The chamber 350 d preferably is conical in shape, andpreferably is configured to receive hemostatic material 270 thereinbetween the catheter and the wall. The proximal end 352 of the deliverytube 350 also is preferably configured to receive at least a distalportion of the pusher member 330. The distal end 354 of the deliverytube 350 has a distal opening that is configured to receive the catheter310 extending therethrough.

With particular reference to FIG. 21, the delivery tube 350 preferablycomprises weakened portions 356. In the illustrated embodiment, theweakened portions 356 comprise portions of the tube 350 having a reducedthickness “t”. The reduced thickness weakened portions 356 preferablyextend from at or near the proximal end 352 to the distal end 354 of thedelivery tube 350. The weakened portions 356 define a preferentialbreaking or deformation zone of the delivery tube 350 so that when aforce beyond a specified threshold is applied, the tube will deform orbreak in the vicinity of the weakened portions 356. In the illustratedembodiment, the delivery tube 350 has two weakened portions 356comprising elongate sections of reduced thickness “t” diametricallyopposed to each other. Preferably, the elongate weakened portions 356extend the entire length of the delivery tube 350.

In accordance with this description, the term weakened portion is abroad term used in its ordinary sense and referring to, withoutlimitation, a zone or area that preferentially breaks, bends, stretches,expands or otherwise deforms upon application of a threshold force. Inthe illustrated embodiment, the weakened portions comprise portions thatare relatively thin. In accordance with other embodiments, a weakenedportion can include, without limitation, a portion of material that isscored, perforated, physically or chemically treated, or the like.Further, a weakened portion can comprise an elastic or easily deformablematerial that may or may not be a different material than the rest ofthe member.

In the illustrated embodiment, as shown in FIG. 21, the delivery tube350 has two weakened portions 356. However, it is to be understood thatthe delivery tube 356 can have one or a plurality of weakened portions356.

In one embodiment, the delivery tube 350 preferably comprises separationstarter portions 358 disposed at the proximal end 352. The starterportions 358 are preferably disposed adjacent and aligned with theweakened portions 356. In the illustrated embodiment, the starterportions 358 are notches 358 aligned with the weakened portions 356. Inother embodiments starter portions 358 can be provided having othershapes.

The delivery tube 350 further comprises a coupling portion 360 disposedat the proximal end 352. The coupling portion 360 preferably isconfigured to mechanically couple to the pusher member distal couplingmember 344. With reference to FIG. 22, the illustrated coupling portion360 a comprises a catch configured to releasably hold the raised portionof the pusher member distal coupling member 344. To engage the couplingportions 244, 260, the delivery tube 350 is moved longitudinallyrelative to the pusher member 344 until the catch is aligned with theraised portion, at which time the raised portion will enter the catch.The catch and raised portion are configured so that the raised portionwill exit the catch only upon application of a threshold force. Thus,the pusher member 330 and tube 350 are releasably coupled andlongitudinally fixed relative to one another.

With reference again to FIG. 20, the delivery tube 350 comprises ahandle 362 disposed adjacent the proximal end 352. The handle 362preferably comprises two opposing support arms that extend outward fromthe conical outer surface 350 b at locations spaced from the weakenedportions 356. In the illustrated embodiment, the delivery tube handle362 comprises two support arms diametrically opposed to each other anddisposed generally 90° from the weakened portions 356.

With reference again to FIG. 17, the vascular wound closure assembly 300is assembled by sliding the distal end 314 of the catheter 310 throughthe canal 330 a of the pusher member 330 so that the proximal end 332 ofthe pusher member 330 preferably abuts the stopper member 316, and sothe distal end 314 of the catheter 310 extends out from the distal end334 of the pusher member 330. The coupling member 320 engages the stopmember 316 and pusher member proximal coupling member 342 so that thepusher member 330 is fixed longitudinally to the catheter 310.

The proximal end 352 of the delivery tube 350 is slid over the distalend 314 of the catheter 310 so that the catheter 310 travels through theopening 350 d. As the delivery tube 350 is slid proximally over thecatheter 310 the coupling portion 360 mechanically engages the distalcoupling member 344 of the pusher member 330. As such, the catheter 310,pusher member 330 and delivery tube 350 are fixed longitudinally to oneanother. Thus, the pusher member and tube move together as a unit. Thehemostatic material 270 can be added to the chamber 350 d of thedelivery tube 350 before or during the assembly process.

With continued reference to FIG. 17, when the apparatus is assembled,the distal end 314 of the catheter 310 extends from the distal end 354of the delivery tube 350, and the catheter holes 318 preferably arespaced from the distal end 354 a distance at least the same as the widthof an artery wall. Preferably, the distance is about 0.5 to 2millimeters.

To use the apparatus, the assembled device is advanced into the vascularwound “w” in a manner similar to that discussed above in connection withFIGS. 1-4. When the device is positioned so that the distal end 354 ofthe delivery tube 350 is generally adjacent the wound “w”, the couplingmember 320 preferably is disengaged from the stop member 316 of thecatheter 310 and the proximal coupling member 342 of the pusher member330. Similarly, the coupling portion 360 of the delivery tube 350preferably is disengaged from the distal coupling member 344 of thepusher member 330. Accordingly, the pusher member 330 and delivery tube350 are no longer longitudinally fixed relative to each other.

With reference next to FIG. 23, the pusher member 330 is then preferablyadvanced distally into the opening 350 d of the delivery tube 350 whilethe delivery tube 350 is held generally stationary adjacent the wound w.Since the pusher member 330 is generally larger in diameter than thedelivery tube 350, the delivery tube 350 breaks along the weakenedportions 356 as the pusher member 330 is advanced. In one embodiment, auser grasps the handle 340 of the pusher member 330 and the handle 362of the delivery tube 350 to drive the pusher member 330 through thedelivery tube 350.

As the delivery tube 350 breaks, openings are created so that thehemostatic material 270 is free to exit the chamber. As the pushermember 330 advances, it engages and advances the hemostatic material 270out of the tube 350 and into contact with the wound “w”. Preferably, thebroken portions of the delivery tube 350 are removed from the woundlocation.

As described above in connection with other embodiments, the catheter310 can be slidably withdrawn through the canal 330 a of the pushermember 330. Further, a release rod (not shown) can also be used toprovide counter traction to help remove the pusher member 330 from thewound location. For example, the release rod can be slidably insertedthrough the canal 330 a of the pusher member 330 so that it engages thehemostatic material 270 against the wound location. A user can thenremove the pusher member 330 without disturbing the hemostatic material270 because the counter traction provided by the release rod will keepthe hemostatic material 270 in place as the pusher member is removed.

In the embodiment discussed above, the coupling members are disengagedbefore advancing the pusher member relative to the delivery tube. It isto be understood that, in other embodiments, the coupling members can beadapted so that mere application of a force above a threshold forcelevel will defeat the coupling members so as to release the releasablycoupled members from one another. Thus, as the user applies force toadvance the pusher member, the user simultaneously disengages thecoupling members and advances the pusher member.

In another embodiment, the distal coupling member of the pusher memberis threaded on its outer surface, and the proximal coupling member ofthe delivery tube is threaded on its inner surface. As such the pushermember and delivery tube are threadably affixed to each other. In thisarrangement, the pusher member is advanced relative to the delivery tubeby threading the pusher member. This arrangement allows the user toadjust the distance between the distal ends of the delivery tube and thecatheter indicator holes. When the device is positioned so that thedelivery tube is adjacent the wound, the pusher member is advanced bycontinuing to thread the pusher member into the delivery tube as thedelivery tube is held in place. As such, the pusher member will advance,and will eventually break the tube at the weakened portions. The pushermember can then be advanced further by using the handles.

In still other embodiments, other types and structures of couplingmembers can be employed. For example, various releasable lockingstructures can be employed, such as a J-lock or an L-lock (see FIG. 24).Additionally, in still further embodiments, the coupling members canhave still different structure. For example, the coupling member cancomprise an adhesive between the pusher member and catheter, whichadhesive is configured to be defeated upon application of a thresholdforce. In yet a further embodiment, the pusher member and catheter arelightly heat bonded or otherwise bonded together. As such, the bondbetween the pusher member and catheter will be overcome upon applicationof a threshold force.

FIGS. 25-28 illustrate another embodiment of a vascular closureapparatus 300′ having many aspects similar to the embodiment describedabove with reference to FIGS. 17-23. Where possible, the same referencenumerals are used to identify similar elements, but elements of thepresent embodiment include the appellation “′”.

With specific reference to FIG. 25, the closure apparatus 300′preferably comprises a catheter 310′, a pusher member 330′, and adelivery tube 350′ releasably connected to each other. Additionally, theapparatus 300′ preferably comprises a threaded coupling member 344′slidably disposed about the pusher member 330′.

With specific reference next to FIG. 26, the catheter 310′ preferablycomprises an unthreaded stop member 316′. Additionally, a couplingmember 320′ preferably is configured so that a portion of the couplingmember is slidable over the stop member 316′ so as to enclose it.However, a proximal portion of the coupling member cannot slide over thestop member 316′, and thus the stop member limits the distal travel ofthe coupling member.

With reference next to FIGS. 25 and 27, the proximal end 332 of thepusher member 330′ is configured to abut against the stop member 316′when the pusher member 330′ is slidably disposed on the catheter 310′.The threaded outer surface of the proximal coupling member 342preferably is configured to mechanically engage the threads of thecoupling member 320′ when said member 320′ is advanced over the proximalend 332 of the pusher member 330′.

The pusher member 330′ preferably comprises a transition portion 337′adjacent the distal portion 338. The transition portion 337′ preferablycomprises a cylindrical raised portion 337 a′ and a generally conicalportion 337 b′. The raised portion 337 a′ comprises an unthreaded outersurface, and preferably is configured to slidably receive a distalportion of the coupling member 344′ about and over its outer surface sothat the coupling member 344′ encloses the raised portion 337 a′. Aproximal portion of the coupling member 344′ cannot slide over theraised portion 337 a′, and thus the raised portion 337 a′ limits distaltravel of the coupling member 344′ over the pusher member 330′.

With reference to FIGS. 25 and 28, the delivery tube 350′ preferablycomprises a coupling portion 360′ at its proximal end 352. The couplingportion 360′ preferably includes a threaded outer surface 360 a′configured to mechanically engage the coupling member 344′. In onepreferred embodiment, the delivery tube 350′ comprises weakened portions356, as previously discussed. In another preferred embodiment, the body350 a′ of the delivery tube 350′ comprises two separate halves 350 f,350 g configured to abut against each other about an axis “z” and beheld in a generally fixed position relative to each other when thecoupling member 344′ is threaded onto the coupling portion 360′. In yetanother preferred embodiment, the delivery tube 350′ comprises a body350 a′ with two halves 350 f, 350 g joined at the proximal end 352 ofthe delivery tube 350′ by weakened portions 356′. In another embodiment,the two halves are joined by an elastic member which helps hold thehalves together before the hemostatic material is deployed.

With reference again to FIG. 25, the vascular closure apparatus 300′preferably is assembled so that the catheter 310′, the pusher member330′, and the delivery tube 350′ are releasably coupled by the couplingmembers so as to be fixed relative to each other. For example, thecatheter 310′ is slidably inserted into the pusher member 330′ until thestopper member 316′ abuts against the proximal end 332 of the pushermember 330′. The coupling member 320′ is then slid over the stoppermember 316′ and threaded onto the proximal coupling member 342 of thepusher member 330′. The delivery tube 350′ is similarly slid over thecatheter 310′ and pusher member 330′ until the proximal end 352 of thedelivery tube 350′ abuts against the transition portion 337′, whereinthe delivery tube 350′ preferably encloses the hemostatic material 270therein. The coupling member 344′ is then slid over the raised portion337 a′ and threadably engages the coupling portion 360′.

As previously discussed, once the device is in place adjacent the wound“w”, the coupling members 344′, 320′ are disengaged so that the pushermember 330′ is uncoupled from the catheter 310′ and the delivery tube350′. The user advances the pusher member 330′ into the delivery tube350′ to deform the tube and engage and advance the hemostatic material270 adjacent the wound “w”.

In the embodiments just discussed, the delivery tube is configured tobreak when the pusher member is advanced. In other embodiments, thedelivery tube may not break, but deforms sufficiently so that materialwithin the tube can be dispatched therefrom. For example, at least aportion of the tube may be formed of an elastic material, such assilicone, so that the pusher member deforms the tube and forces materialout of the tube and adjacent the wound. Additionally, in one embodimentwherein the tube is formed of an elastic material, the tube does notnecessarily include a weakened portion. This principle can also beemployed in connection with other embodiments discussed herein,including the following embodiments.

FIGS. 29-37 illustrate another embodiment of a vascular closureapparatus 300″ having many aspects similar to the embodiments describedabove with reference to FIGS. 17-23 and to FIGS. 25-29. Where possible,the same reference numerals are used to identify similar elements, butelements of the present embodiment include the appellation “′”. Ofcourse, it is to be understood that similar elements do not necessarilyshare identical structure.

With specific reference to FIG. 29, the closure apparatus 300″preferably comprises a catheter 310″, a pusher member 330″, and adelivery tube 350″ releasably connected to each other.

With reference also to FIG. 30, the catheter 310″ preferably comprisesan unthreaded stop member 316″ that is raised relative to the catheterbody. Additionally, a coupling member 320″ preferably is configured sothat a portion of the coupling member is slidable over the stop member316″ so as to enclose it. However, a proximal portion of the couplingmember 320″ cannot slide over the stop member 316″, and thus the stopmember limits the distal travel of the coupling member 320″.

With reference next to FIGS. 29 and 31, the pusher member 330″preferably is elongate and is slidable over the catheter 310″. Aproximal end 332″ of the pusher member 330″ is configured to abutagainst the stop member 316″ when the pusher member 330′ is slidproximally over the catheter 310″. The threaded outer surface of theproximal coupling member 342″ of the pusher 330″ preferably isconfigured to mechanically engage the threads of the coupling member320″ when said coupling member 320″ is advanced over the proximal end332″ of the pusher member 330″. As such, the pusher member 330″ isreleasably coupled to the catheter 310″ with the proximal end 332″abutting the stop member 316″.

The threaded outer surface of the proximal coupling member 342″preferably is also configured to mechanically engage a threaded handle340″. With reference also to FIGS. 32 a, 32 b, and 33, the illustratedhandle 340″ comprises a handle support 370 and a handle arm 371. Thehandle support 370 comprises an elongate body 365 and a flange 367.Preferably, the body 365 has a square or rectangular shaped profile thatcorresponds with a square or rectangular shaped hole 369 defined in thehandle arm 371, such that in an engaged configuration, the handlesupport 370 rotates together with the handle arm 371. The flange 367also preferably has a square or rectangular profile. The handle arm 371preferably is slidable relative the handle support body 365 in an axialdirection, and thus preferably can be removed from the handle support370 and passed over the stop member 316″ of the catheter when thecoupling member 320″ is uncoupled from the proximal coupling member342″. It is to be understood that, in other embodiments, any suitablemechanism, such as a detent, can be used to releasably couple the armhandle 371 to the support 370.

The pusher member 330″ preferably comprises a central shaft section 372that is unthreaded and has a reduced diameter relative the threadedouter surface of the proximal coupling member 342″. The central shaftsection 372 preferably is located between the proximal coupling member342″, having a raised threaded outer surface, and a distal couplingmember 374, also having a raised threaded outer surface.

With continued reference to FIGS. 29 and 31, the pusher member 330″preferably comprises an adjustable stopper 337″ adjacent the distalportion 338″. The adjustable stopper 337″ preferably comprises acylindrical raised portion 337 a″ and a generally conical portion 337b″. The raised portion 337 a″ comprises an unthreaded outer surface anda threaded inner surface. The threaded outer surface of the distalcoupling member 374 of the pusher member 330″ preferably is configuredto mechanically engage the threads of the adjustable stopper 337″ whenthe adjustable stopper 337″ is advanced over a distal portion 338″ ofthe pusher member 330″.

A coupling member 344″ is slidably disposed about the pusher member330″. The raised portion 337 a″ of the adjustable stopper 337″preferably is configured to slidably receive a distal portion of thecoupling member 344″ about and over its outer surface so that thecoupling member 344″ encloses the raised portion 337 a″. However, aproximal portion of the coupling member 344″ cannot slide over theraised portion 337 a″, and thus the raised portion 337 a″ limits distaltravel of the coupling member 344″ over the pusher member 330″.

With reference next to FIG. 34, the proximal portion of the couplingmember 344″ preferably defines a hole 368 that is sized and configuredsuch that the coupling member 344″ cannot slide distally over theadjustable stopper 337″, but can slide proximally over the central shaftsection 372, the handle support 370, and the catheter stop member 316″.In the illustrated embodiment, the hole 368 is generally complementaryto the handle support flange 367. Thus, when the coupling member 320″and the handle 371 have been removed, the coupling member 344″ can alsobe removed if desired. The handle arms 371 can be replaced on the handlesupport 370 after the coupling member 344″ has been removed.

The distal portion of the coupling member 344″ preferably comprises athreaded portion 376 on an inner surface. The threaded portion 376preferably comprises threads covering a proximal portion of the innersurface of the coupling member 344″. Preferably, a distal portion of theinner surface of the coupling member 344″ is not threaded.

With reference next to FIGS. 29 and 35-36, the delivery tube 350″comprises a body 350 a″ made up of two separate halves or segments 350f″, 350 g′.′ The segments 350 f′, 350 g″ are formed separately but areconfigured to abut against one another about an axis “z” to form thedelivery tube 350″. Preferably a first segment 350 g″ has guide portions380 that are configured to fit into recesses 381 formed in a secondsegment 350 f′ in order to properly align the segments to form thedelivery tube 350″.

Each segment 350 f′, 350 g″ has a generally concave inner surfaceconfigured so that the tube 350″, when assembled, fits concentricallyabout the catheter 310″. In the illustrated embodiment, the innersurface defines a chamber between the catheter 310″ and inner surfacewhen the tube 350″ is in place. Preferably, at least a distal portion ofthe chamber is tapered so that the diameter of the chamber decreasessmoothly toward the distal end thereof.

The delivery tube 350″ has a coupling portion 360″ at its proximal end352″. The coupling portion 360″ preferably includes a threaded outersurface 360 a″ configured to mechanically engage the coupling member344″. When the coupling member 344″ is threaded onto the couplingportion 360″, as shown in FIG. 37, the segments 350 f′, 350 g″ are heldin a generally fixed position relative to each other. It is to beunderstood that other structures may be used to releasably couple thesegments 350 f′, 350 g″. Also, in other embodiments, the delivery tube350″ may comprise a body 350 a″ having several releasably coupledsegments at or near the proximal end 352″ of the delivery tube 350″.

With reference again to FIG. 29, the adjustable stopper 337″ preferablycontacts an upper portion of the assembled delivery tube 350″. Theadjustable stopper 337″ can be advanced proximally or distally relativethe pusher member 330″ by rotating the adjustable stopper 337″. When thecatheter 310″, the pusher member 330″ and the delivery tube 350″ are tobe coupled together, moving the adjustable stopper 337″ proximally ordistally relative the pusher member 330″ prior to coupling the pushermember 330″ with the delivery tube 350″ effectively adjusts the positionof the delivery tube 350″ relative the catheter 310″. Accordingly,another feature of this embodiment is that the position of the distalend of the delivery tube 350″ can be adjusted relative the holes in thecatheter 310″ by movement of the adjustable stopper 337″. This may bedesirable to adjust the delivery tube 350″ position relative the holesin the catheter 310″ based on the thickness of a particular blood vesselwall and/or the preference of a clinician. For example, a clinician mayadjust the stopper 337″ so as to position the distal end of the deliverytube 350″ at a desired position between about 1 mm and 1 cm proximal ofthe holes of the catheter 310″.

The threaded inner surface 376 of the coupling member 344″ preferably isconfigured to mechanically engage the threads of the coupling portion360″ when the coupling member 344″ is advanced over the stopper 337″ andfurther over a proximal end 352″ of the delivery tube 350″. Accordingly,another feature of this embodiment is that the delivery tube 350″ issecurely coupled with the pusher member 330″ through the coupling member344″. The coupling member 344″ also helps hold the body segments 350 f″,350 g″ together. Because only a portion of the inner surface of thecoupling member 344″ is threaded, the pusher member 330″ and thedelivery tube 350″ can be quickly and easily decoupled.

With reference next to FIGS. 37-39, the vascular closure apparatus 300″preferably is assembled so that the catheter 310″, the pusher member330″, and the delivery tube 350″ are releasably coupled by the couplingmembers so as to be fixed relative to each other. For example, thecatheter 310′ is slidably inserted into the pusher member 330″ until thestopper member 316″ abuts against the proximal end 332″ of the pushermember 330″. The coupling member 320″ is then slid over the stoppermember 316″ and threaded onto the proximal coupling member 342″ of thepusher member 330″. The hemostatic material 270 preferably is wrappedabout the catheter 310″ adjacent a distal end of the pusher member 330″,and the delivery tube 350″ is positioned over the catheter 310″ so thatthe hemostatic material is enclosed within the chamber. The deliverytube 350″ is positioned over part of the catheter 310″ and pusher member330″ so that the proximal end 352″ of the delivery tube 350″ abutsagainst the adjustable stopper 337″. The coupling member 344″ is thenslid over the raised portion 337 a″ and threadably engages the couplingportion 360″. Before coupling the pusher and tube, the clinician mayadjust the position of the tube relative to the catheter by advancing orretracting the adjustable stopper 337″. Preferably, the delivery tube350″ is arranged on the catheter 310″ so that the distal end of the tube350″ is between about 1 mm to 1 cm proximal of the catheter holes.

As previously discussed, once the fully assembled device is in placeadjacent the wound “w”, the coupling members 344″, 320″ are disengagedso that the pusher member 330″ is uncoupled from the catheter 310″ andthe delivery tube 350″, as shown in FIG. 38. The handle 340″ preferablyis removed momentarily so that the coupling member 344″ can be removedover the handle support 370. The handle 340″ preferably is replaced andthe adjustable stopper 337′ preferably is moved proximally to thecentral shaft section 372 so that it can slide freely and will notrestrict advancement of the pusher member 330″ relative the deliverytube 350″.

As best shown in FIG. 39, as the clinician advances the pusher member330″ into the delivery tube 350″, the distal end of the pusher member330″ engages the hemostatic material 270 and advances toward the wound“w”. As the user advances the pusher member 330″ into the delivery tube350″, a distal portion 338″ of the pusher member 330″ preferablycontacts the tapered inside surface of the delivery tube chamber, thusat least partially separating the segments 350 f′, 350 g′ of thedelivery tube 350″. This allows the hemostatic material 270 to bedeployed from the chamber and onto the blood vessel at or adjacent thewound.

The distal portion 338″ of the pusher member 330″ preferably contactsthe inside surface of the delivery tube 350″ in a distal portion of thetube. For example, in one embodiment, the pusher member 330″ firstengages the tapered inner surface at a point distal the halfway point ofthe length of the tube. In another embodiment, the first engagementpoint is between about ⅔ and ¾ of the way into the delivery tube 350″.

In accordance with one embodiment, preferably the apparatus isconfigured so that the stopper 337″ is advanced over just one or a fewthreads of the pusher member distal coupling member 374 when theapparatus is assembled. As such, to deploy the hemostatic material 270,rather than first retracting the stopper 337″, the clinician may simplytwist the handle to advance the pusher relative to the stopper 337″.Soon the stopper 337″ will become unthreaded from the coupling member374 and will slide freely over the central shaft section 372, allowingthe clinician to quickly and easily advance the pusher member 330″.

In the embodiments just discussed, the delivery tube segments 350 f′,350 g″ are configured to separate when the pusher member 330″ isadvanced. In some embodiments, the delivery tube segments may completelyseparate, while in other embodiments, only portions of the delivery tube350″ may separate. Preferably, at least the distal portions of the tubeseparate. The segments preferably are configured such that advancementof the pusher member 330″ engages the delivery tube 350″ so thatmaterial within the tube can be dispatched therefrom.

With reference to FIGS. 40, 41 and 42 a-b, a vascular wound closureassembly 430 includes an elongate catheter 432 having a distal end 434and a proximal end 436. A distal opening 438 is formed through thedistal end 434 of the catheter 432 and opens along a longitudinal axisof the catheter 432. The catheter 432 includes a tapered tip 4440 at thedistal end 434. An elongate main body 42 of the catheter 432 is disposedproximal the tapered tip 4440. Preferably the main body 42 has asubstantially uniform diameter along its length. A lumen 444 extendslongitudinally within the catheter 432 from the distal opening 438 tothe proximal end 436.

A connector portion 446 is provided on the proximal end 436. Theconnector portion 446 includes a main lumen 448 and a secondary lumen450. The main lumen 448 extends along the longitudinal axis of thecatheter 432 and is coextensive with the catheter lumen 444. Thesecondary lumen 450 extends outwardly from the main lumen 448, butcommunicates with the main lumen 448 and the catheter lumen 444. Aproximal opening 452 is provided at the proximal end of the main lumen448 and, like the distal opening 438, opens along the longitudinal axis.A secondary opening 454 opens into the secondary lumen 450.

The distal and proximal openings 438, 452 are sized and adapted toaccommodate a guidewire 458 such as the guidewire used in angioplastyand other vascular surgeries. As such, the guidewire 458 can be threadedthrough the catheter 432 and the catheter can be advanced over theguidewire 458.

A hole 460 is formed through a side-wall of the catheter 432 near thedistal end of the catheter. In another embodiment, at least two holesare provided. All of the holes preferably are disposed substantially thesame distance from the distal end of the catheter.

With continued reference to FIGS. 40, 41 and 42 a-b, a vacuum or othersource of suction 464 is provided and communicates, through tubing 466,with the secondary lumen 450 of the catheter connector portion 446.Thus, a vacuum is drawn through the catheter lumen 44. Preferably, thedistal and proximal openings 438, 452, which accommodate the guidewire458, are sized so that the guidewire 458 substantially plugs theopenings; thus, the vacuum is drawn through the hole 460. A viewing port468 is arranged between the source of suction 464 and the catheter 432.The viewing port 468 is configured to allow a clinician to view thematerial that is drawn by suction through the hole and through thecatheter lumen 44.

A delivery tube 490 is disposed over the catheter 432 proximal of thehole 460. A pusher member 500 also is disposed over the catheter 432generally proximal of the delivery tube 490. The delivery tube 490 andpusher member 500 will be discussed in more detail below. The deliverytube 490 and pusher member 500 preferably are selectively secured to thecatheter 432 so that they are in a fixed position relative to thecatheter. More specifically, the delivery tube 490 preferably isreleasably secured to the catheter 432 so that a distal end 502 of thedelivery tube 490 is spaced a distance between about 0.5 to 1.5 cmproximal of the hole 460. More preferably, the distal end 502 of thedelivery tube 490 is spaced less than about 1 cm from the hole.

With reference also to FIG. 43, the illustrated vascular wound closureassembly 430 can be precisely positioned adjacent a subcutaneousvascular wound “w” in order to close the wound. With reference to FIGS.40-43 and 50, in order to precisely locate and provide access to afemoral artery puncture wound w, the catheter 432 is first threaded overthe guidewire 458, which has been previously inserted into the patient'sfemoral artery 94 through the puncture wound w. The lumen 444 isattached to the source of suction 464 and the assembly 430 is advancedover the guidewire 458 through a patient's tissue 96 so that the distaltip 440 of the catheter 432 extends through the vascular puncture woundw.

As the assembly 430 is advanced, the source of suction 464 draws bodilyfluids through the hole 460. The fluids pass through the viewing port468, which allows the clinician to identify the fluids being withdrawn.The viewing port 468 can have any suitable structure or location. Forexample, the viewing port can comprise clear tubing attached to thecatheter, a substantially transparent syringe that functions as both asource of suction and a viewing port, or a portion of the catheter thatis substantially transparent. Most preferably, the catheter 432 isformed of a transparent material so that the clinician becomes aware assoon as blood begins to be drawn through the catheter.

When the hole 460 passes the artery wall 98 and enters the blood vessel94, as shown in FIG. 43, blood “b” begins to be drawn through the hole460 into the catheter 432 and is conducted past the viewing port 468.Thus, when blood b is observed in the viewing port 468, the clinicianwill know that the hole 460 has just passed into the puncture wound wand that the distal end 502 of the delivery tube 490 thus positionedadjacent the outer wall 98 of the artery 94, preferably within about 1cm of the artery wall 98.

With reference next to FIG. 44, the delivery tube 490 is generallyelongate and comprises first and second separately-formed members 492,494 that engage one another to form the delivery tube 490. Each tubemember 492, 494 has a distal end 502, a proximal end 504, an outersurface 506 and an inner surface 508. Guide posts 510 formed on one ofthe tube members 492, 494 fit into guide recesses 512 formed in theother member so as to align the tube members 492, 494. When connectedand aligned as shown in FIG. 4, the tube members 492, 494 form thedelivery tube 490. As shown, the proximal end 504 of the delivery tube490 preferably is threaded on its outer surface 506. A handle portion514 is disposed distal of the proximal end 504, and the delivery tube490 generally tapers from the handle 514 to the distal end 502.

A chamber 520 is formed within the delivery tube 490, and the catheter432 extends therethrough. At the distal end 502 of the delivery tube490, the chamber 520 is just large enough to accommodate the catheter432. However, as the tube tapers in a proximal direction, a space 522 isdefined between the catheter 432 and the inner surface 508 of the tube490. In the illustrated embodiment, the space 522 is packed with atherapeutic agent, preferably a hemostatic material 270 that can bedelivered from the tube 490 subcutaneously and adjacent the vascularwound w. A distal end 528 of the pusher member 500 is accommodatedwithin the proximal end 504 of the delivery tube 490.

In a preferred embodiment, the hemostatic material 270 comprises ahydrophilic fibrous fleece. Throughout this description, the term fleeceis used as a broad term in its ordinary sense and refers to, withoutlimitation, in a non-woven or a woven cloth form or in a puff or ballform. It is to be understood that the fibrous fleece may be treated orcoated in any suitable manner to enhance its hydrophilic propertiesand/or its hemostatic properties. In a preferred embodiment, fibrouschitosan fleece is treated to deposit a hemostatic agent thereon. Mostpreferably, microporous polysaccharide microspheres are deposited on thefleece.

With reference next to FIG. 45, the pusher member 500 comprises anelongate body 530 and has distal and proximal ends 528, 532. A lumen 534is formed longitudinally through the pusher member 500, and preferablyis sized to slidably accommodate the catheter 432 therethrough.Preferably, the pusher member 500 is rigid enough so that it can begrasped at or near its proximal end 532 and pushed forward, in turnengaging and pushing the hemostatic material 270 within the deliverytube 490, without binding or bending excessively. The distal portion 528of the pusher member 500 is configured to fit within a proximal portion504 of the delivery tube 490. However, the distal portion 528 of thepusher member 500 preferably has a greater diameter than at least aportion of the delivery tube 490 near the distal end 502 of the deliverytube 490. As such, when the pusher member 500 is advanced relative tothe delivery tube 490, the pusher member 500 engages the inner surface508 of the tube members 492, 494 and forces them apart so as to deploythe hemostatic material 270 from within the delivery tube 490.

In the illustrated embodiment, the pusher member 500 is threaded alongits proximal end 532. An annular ridge 540 is formed a distance “d” fromthe distal end 528 of the pusher member 500. The annular ridge 540projects radially outwardly a very small distance from an outer surfaceof the pusher member 500. Since the annular ridge 540 projects only avery small distance from the surface of the pusher member 500, it doesnot interfere with the pusher member's slidability into the proximal end504 of the delivery tube 490.

In the illustrated embodiment, the pusher member 500 has a diameter ofabout 4 mm and a lumen diameter 534 of about 2 mm. The annular ring 540extends outwardly from the outer surface a distance of between about 0.1mm to 0.25 mm, and, more preferably, about 0.15 mm.

With reference also to FIG. 46, which shows a close up view of thedistal portion 528 of the pusher member 500 as installed on the deliverytube 490, preferably a pair of elastomeric annular locking members 544are disposed around the pusher member 500. The locking members 544preferably are arranged immediately adjacent either side of the annularridge 540, and are sized so as to engage the proximal end 504 of thedelivery tube 490 so as not to slide into or over the delivery tube 490.Preferably, the elastomeric locking members 544 are fit about the pushermembers 500 so that they can be slid along the pusher member 500, andeven can slide over the annular ridge 540.

An internally threaded locking cap 546 is configured to be threaded ontothe proximal end 504 of the delivery tube 490. The locking cap 546 hasproximal wall 548 having a hole 549 formed therethrough. The hole 549 issized to accommodate and slide over the pusher member body 530. Asshown, the locking members 544 are arranged on the pusher member body530 adjacent either side of the annular ridge 544, and the pusher member500 is inserted into the delivery tube 490 until the locking members 544engage the proximal end 504 of the delivery tube 490. The cap 546 isthen advanced over the pusher member 500 and threaded into place on thedelivery tube 490. As the cap 546 is tightened, the proximal wall 548 ofthe cap 546 engages the locking members 544, which are then compressedlongitudinally between the cap proximal wall 548 and delivery tubeproximal end 504. Due to their elastomeric properties, as the lockingmembers 544 are compressed longitudinally, they expand laterally, andthus tightly engage the pusher member 500 at and adjacent the annularridge 544.

In the illustrated embodiment, the locking members 544 tightly engagethe annual ridge 540 such that they resist sliding over the ridge. Sincea locking member 544 is disposed on each side of the ridge 540, thepusher 500 is thus prevented from sliding in either a proximal or adistal direction relative to the tube 490. However, once the cap 546 isloosened and the locking members 544 are released from compression, theannular ridge 540 is slidable through the locking members 544, and thepusher 500 is correspondingly slidable.

In the illustrated embodiment, the locking cap 546 and delivery tube 490are threaded. It is to be understood that any other fastening mechanismmay be employed, such as for example a J-lock or detent.

The illustrated embodiment employs an annular ridge 540 disposed on thepusher member 500. It is to be understood, however, that otherconfigurations employing a similar principle can be acceptable. Forexample, any type of protuberance, including a bump, a series of bumps,spikes or any other protuberance that projects from a surface of thepusher member 500 can be employed. Further, protuberances can beemployed at only one area disposed a predictable distance from thedistal end of the pusher member as shown in the illustrated embodiment,or, in other embodiments, can be disposed at various locations or evencontinuously along the pusher member so as to allow customization andoptimization of the placement and locking position of the pusher memberrelative to the delivery tube. Further, in other embodiments, ratherthan a series of bumps or the like, the pusher member surface can betreated to create a surface roughness, such as by being sanded with alow grit sandpaper, or to be pitted. In such an instance, protuberancesare considered to extend from the lowest portions of the pits, groovesor the like. When the locking members 544 are longitudinally compressed,the locking members will expand transversely and tightly engage at leastportions of the pits and protuberances so as to fix the pusher member500 in position relative to the delivery tube 490. As such, aprotuberance is considered to be any surface aspect upon which a lockingmember may obtain purchase to grip the pusher member when the cap istightened.

In the illustrated embodiment, the locking members 544 compriseelastomeric rings. It is to be understood that, in other embodiments,the locking members may be shaped differently, and may extend aroundonly a portion of the pusher member. Further, although the illustratedembodiment shows two locking members 544 disposed one on either side ofthe annular ridge 540, it is to be understood that other embodiments mayemploy only a single locking member, or more than two locking members,configured to releasably engage an annular ridge or other protuberanceconfiguration. In still another embodiment, one or more locking membersare employed, but no protuberances are formed on the pusher membersurface. In this embodiment, the locking members are pushed tightlyagainst the pusher member when the cap is tightened so as to increasethe friction between the locking members and the pusher member, andaccordingly resist movement of the pusher member relative to thedelivery tube.

With reference next to FIG. 47, the catheter 432 preferably comprises astop member 550 extending radially outwardly from the catheter surface.In the illustrated embodiment, the stop member 550 comprises an annularring; however, it is anticipated that any sort of protuberance can beemployed. With reference also to FIG. 48, a coupling member 552preferably is movably disposed about the catheter 432 and is configuredto mechanically couple to the proximal end 532 of the pusher member 500.In the illustrated embodiment, the coupling member 552 is threaded onits inner surface in order to engage the threaded proximal end 532 ofthe pusher member 500. When the coupling member 552 and pusher member500 are engaged, the catheter stop member 550 is locked between theproximal end 532 of the pusher member 500 and a proximal wall 554 of thecoupling member 552. As such, the catheter 432 is selectively fixed inposition relative to the pusher member 500. As discussed above, thepusher member 500 is selectively fixed in position relative to thedelivery tube 490. As such, when the locking cap 546 and coupling member552 are engaged as discussed above, the catheter 432, pusher member 500and delivery tube 490 are all in fixed positions relative to oneanother.

In another embodiment, the catheter 432 comprises a protuberance, suchas an annular ring, and one or more locking members are provided so asto releasably secure the pusher member 500 to the catheter 432 when thecoupling member 552 is engaged.

With reference next to FIG. 49, a collar 560 is illustrated. Theillustrated collar 560 preferably is made of a polymer formed as abroken ring. As such, the collar 560 is resilient and circumferentiallyexpandable.

With reference also to FIGS. 40-43, 50 and 51, the collar 560 preferablyis configured to fit about the delivery tube 590. A relaxed diameter ofthe collar 560 is less than the diameter of at least most of the taperedportion of the delivery tube 490. Thus, the collar 560 iscircumferentially expanded in order to fit over the delivery tube 490.Such circumferential expansion is resisted by the collar 560 so that thecollar 560 exerts an inwardly-directed force on the delivery tube 490.In order to ease advancing of the tube through tissues, the outerdiameter of the delivery tube 490 is made quite small. As a result, thewidth of the walls of the tube members 492, 494 preferably is quitesmall. In some embodiments, the thin-walled tube members are somewhatflexible. The inwardly-directed force exerted by the collar 560 helpshold the tube members 492, 494 together so as to fit closely about thecatheter 432 and to contain the hemostatic material 270 within thechamber 522.

In the illustrated embodiment, the collar 560 is configured to beslidable over the delivery tube 490. Preferably both the collar 560 anddelivery tube 490 have smooth engaging surfaces. It is to be understoodthat other surface configurations can be used as appropriate. Withreference next to FIGS. 43, 50 and 51, to correctly position the vesselclosure device 430, the assembly is advanced over a guidewire 458 intoposition adjacent the wound w. FIG. 50 shows the assembly 430 partiallyadvanced through body tissues 96 toward a puncture wound w. As theapparatus 430 is advanced, the collar 560 engages the patient's skin, asshown in FIG. 50. As the apparatus is further advanced, the collar 560continues to engage the patient's skin and the delivery tube 490 slidesdistally relative to the collar 560, as shown in FIG. 43. The collarexpands with the diameter of the tapered delivery tube 490 as the tubeslides relative to the collar 560, and the collar continues to exert acircumferential force to help hold the tube closed. It is anticipatedthat the body tissue 96 surrounding the portion of the delivery tube 490distal of the collar 560 also helps to keep the tube closed.

When the apparatus 430 is in a desired position at or adjacent a woundw, as shown in FIG. 43, the coupling member 552 and cap 546 aredisengaged so that the pusher member 500 can be advanced relative to thedelivery tube 490 and catheter 432. With particular reference to FIG.51, as the pusher member 500 is advanced, the distal end 528 of thepusher member 500 engages inner surfaces 508 of the tube members 492,494, thus forcing the tube members 492, 494 apart and deploying thehemostatic material 270 from within the delivery tube chamber 522. Inthe embodiment illustrated in FIG. 51, the tube members 492, 494 areflexible so that they will bend outwardly upon urging from the advancingpusher member 500.

As discussed above, in one embodiment, the hemostatic material 270comprises a hydrophilic fibrous chitosan fleece. Since the fleece ishydrophilic, it sticks to the blood vessel 98 surrounding the wound andto surrounding body tissues 96. Further, since the fleece 270 isfibrous, and since the catheter 432 effectively plugs the wound w as thematerial is deployed, none of the fibrous material passes through thewound into the blood vessel 94. Further, as the catheter 432 is removedfrom the wound w, the fleece readily collapses into the space previouslytaken by the catheter. The fleece has hemostatic properties, and fullysurrounds the wound w, thus aiding relatively quick hemostasis of thewound.

In some embodiments the closure device 430 is assembled so that thedistance from the catheter hole 460 to the distal end 502 of thedelivery tube 490 is about or slightly greater than the width of a bloodvessel wall 98. As such, the delivery tube 490 is arranged immediatelyadjacent the wound w. With continued reference to FIGS. 43 and 51, inthe illustrated embodiment, the distance from the catheter holes-460 tothe distal end 502 of the delivery tube 490 is much greater than thewidth of a blood vessel wall 98, but less than about 1.5 cm. Morepreferably the distance is about 1 cm or less. As such, when thecatheter holes 460 enter the blood vessel 94 and the clinician seesblood enter the viewing port 468, the delivery tube 490 is positionedclose to but spaced from the vessel wall 98. In the illustratedembodiment, this is a safety feature to ensure than the distal ends 502of the delivery tube members 492, 494 do not enter or damage the woundsite w. Upon deployment of the hemostatic material 270, the pushermember 500 pushes the material over the catheter 432 and into contactwith, or into close proximity to, the vessel wall 98 and the wound w. Inaccordance with another embodiment, the delivery tube 490 is spaced fromthe vessel wall 98 a distance of at least about three times thethickness of the vessel wall.

With continued reference to FIG. 51, when the tube members 492, 494 areexpanded upon deployment as illustrated, there is further resistance todistal movement of the tube members 492, 494, thus further contributingto safety. Still further, although the collar 560 is slidable over thedelivery tube 490, it contributes some frictional resistance so furtherdistal movement of the delivery tube 490 relative to the collar 560.

The most common sizes of catheters used for interventions through thefemoral artery are sized about 6F or less. In the embodiment illustratedin FIGS. 40-51, the catheter 432 preferably is about 6.5F in size. Sincethe catheter 432 of the closure device is of greater diameter than thecatheters used by the clinician prior to closure of the wound, thecatheter 432 is large enough to tightly engage the wound edges andeffectively plug the wound. This tight fit of the catheter 432 relativeto the wound w helps prevent hemostatic material 270 from passingbetween the catheter and the wound edges and into the blood vessel 94.It is to be understood that different sizes of catheters may be used forinterventions, and for the closure apparatus. Preferably the closureapparatus catheter 432 has a greater diameter than catheter(s) and othersurgical implements used in the procedure prior to closure. Preferably,the catheter 432 has a diameter about 0-1F, and more preferably about0.5F, greater than earlier-used catheters.

In accordance with still another embodiment, the delivery tube 490comprises indicia printed or otherwise marked thereon. In use, theclinician notes, during initial vascular puncture, the depth of thepuncture. Later, during vessel closure, the indicia on the delivery tube490 serves as a reference for the clinician to verify the depth of thetube and its position relative to the vascular wound. It is to beunderstood that such indicia may be printed on the delivery tube or maybe physically formed as raised or lowered portions of the tube.

In accordance with another embodiment, a vascular wound closureapparatus having features as discussed above in connection with FIGS.12-23, 25-28, 29-37, or 40-51 is provided in a kit for use by aclinician. In this embodiment, the apparatus is formed of a disposable,yet suitable material, such as a medical grade plastic, and is assembledand loaded so that the members are releasably coupled to one another andhemostatic material is disposed in the delivery tube. Although theapparatus may be provided pre-assembled, a clinician may still adjustthe position of the tube relative to the catheter by decoupling the tubeand pusher member, making the adjustment, and then recoupling the tubeand pusher member. The apparatus is sterilized and preferably isdisposed within a closed, sterilized container (not shown) which isconfigured to be opened in a sterile environment such as an operatingroom or catheter lab.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

1. An apparatus for subcutaneously delivering a material, comprising: anelongate delivery tube having a chamber configured to accommodate amaterial therewithin; an elongate pusher member having a distal portionconfigured to slidably extend through at least a portion of the deliverytube so as to push at least a portion of the material out of thedelivery tube; a flexible locking member configured to fit at leastpartially around the pusher member and adapted to expand in a transversedirection when subjected to generally longitudinal compression; whereinthe flexible locking member is disposed adjacent the pusher member sothat when the locking member is subjected to generally longitudinalcompression, the locking member expands transversely to engage thepusher member to increase friction between the pusher member and thelocking member.
 2. The apparatus of claim 1, wherein the pusher memberhas at least one protuberance, and the flexible locking member isdisposed adjacent the protuberance so that when the locking member issubjected to longitudinal compression, the locking member expandstransversely to engage the pusher member protuberance so that the pushermember is restrained from moving relative to the locking member.
 3. Theapparatus of claim 2, wherein the flexible locking member is configuredto engage a proximal end of the delivery tube.
 4. The apparatus of claim3 additionally comprising a locking cap configured to selectivelycompress the flexible locking member between the cap and the proximalend of the delivery tube.
 5. The apparatus of claim 4, wherein thelocking cap is selectively engageable with the delivery tube.
 6. Theapparatus of claim 2, wherein the locking member is substantiallyring-shaped.
 7. The apparatus of claim 2, wherein the protuberancecomprises an annular ring projecting from a surface of the pushermember.
 8. The apparatus of claim 2, wherein the protuberance comprisesat least one bump projecting from a surface of the pusher member.
 9. Theapparatus of claim 2, wherein a surface of the pusher member comprises apit formed therein, and the protuberance projects from the pit.
 10. Theapparatus of claim 2, wherein the protuberance extends outwardly betweenabout 0.05-0.3 mm.
 11. The apparatus of claim 2, wherein theprotuberance extends outwardly between about 0.1-0.2 mm.
 12. Theapparatus of claim 2, wherein the material comprises a hemostaticmaterial.
 13. The apparatus of claim 12, wherein the material ishydrophilic.
 14. The apparatus of claim 13, wherein the material isfibrous.
 15. The apparatus of claim 14, wherein the material comprises achitosan fleece.
 16. The apparatus of claim 15, wherein the materialcomprises a chitosan fleece and a starch.
 17. The apparatus of claim 13,wherein the material comprises chitosan.
 18. The apparatus of claim 2,wherein the delivery tube comprises a plurality of elongate tube membersconfigured to move between an engaged closed position and an openposition
 19. The apparatus of claim 18, wherein the tube members areflexible, and additionally comprising a flexible collar disposed aboutthe tube members, the collar being biased to hold the tube members inthe closed position.
 20. The apparatus of claim 18, wherein the collaris slidable over the delivery tube.
 21. The apparatus of claim 18additionally comprising an elongate catheter, and the delivery tubechamber is configured to accept the catheter extending therethrough andalso to accommodate material therein.
 22. The apparatus of claim 21,wherein the catheter comprises a hole formed through a side wall of thecatheter, and the delivery tube is arranged on the catheter so that adistal end of the tube is proximal the side hole.
 23. The apparatus ofclaim 22, wherein the distal end of the delivery tube is between about5-1.5 mm from the catheter side hole.
 24. The apparatus of claim 22,wherein the distal end of the delivery tube is arranged a distance fromthe side hole at least three times the thickness of the blood vesselwall.
 25. An assembly for closing a vascular wound comprising: adelivery tube configured to accommodate a hemostatic materialtherewithin, the delivery tube having a proximal end and a distal end;an apparatus configured to position the distal end of the delivery tubeadjacent the vascular wound; a pusher member having a distal portionconfigured to fit at least partially through the proximal end of thedelivery tube, a portion of the pusher member having a diameter largerthan the diameter of at least a portion of the delivery tube; and anadjustable stopper disposed about a surface of the pusher member, theadjustable stopper being configured to engage the surface of the pushermember and to selectively move proximally or distally along the surfaceof the pusher member to adjustably couple the apparatus and the deliverytube.
 26. The assembly of claim 25, wherein the pusher member comprisesan unthreaded portion and a threaded portion, wherein the adjustablestopper is located at a first threaded location on the pusher member ina coupled configuration, and wherein the adjustable stopper is locatedat a second unthreaded portion on the pusher member in an uncoupledconfiguration.
 27. The assembly of claim 25, wherein the delivery tubecomprises a plurality of segments coupled together.
 28. The assembly ofclaim 25, wherein the delivery tube encloses a chamber, and at least aportion of the chamber has an inner surface that tapers toward a distalend of the chamber.
 29. The assembly of claim 28, wherein when thepusher member is advanced distally relative to the tube, a distal end ofthe pusher member engages the tapered chamber inner surface so as to atleast partially open the tube.
 30. The assembly of claim 29, wherein thedistal portion of the pusher member is configured to contact a segmentof the delivery tube at a location between about ⅔ and ¾ of the way intothe segment.
 31. The assembly of claim 25, wherein the pusher memberadditionally comprises a removable handle.
 32. The assembly of claim 31,wherein the distal coupling member of the pusher member comprisesdeep-set threads configured to releasably couple the pusher member anddelivery tube.
 33. A surgical method, comprising: accessing asubcutaneous blood vessel by forming a puncture through a wall of theblood vessel; advancing at least one surgical implement through theblood vessel puncture, a major surgical implement of the at least onesurgical implement having a diameter advanced through the puncture thatis greater than or equal to a diameter advanced through the puncture ofany other of the at least one surgical implement; and closing thepuncture, said closing comprising: providing a vessel wound closuredevice comprising a catheter, a hemostatic material disposed on thecatheter, and a pusher member configured to push the hemostatic materialdistally over the catheter; wherein the catheter has a diameter greaterthan the diameter of the major surgical implement advanced through thepuncture, so that the catheter engages wound edges of the puncture in amanner to substantially plug the puncture and prevent hemostaticmaterial from passing between the catheter and the wound edge and intothe blood vessel.
 34. The method of claim 33, wherein the catheter is6.5F.
 35. The method of claim 34, wherein the diameter of the majorsurgical implement advanced through the puncture is no greater than 6F.36. The method of claim 34, additionally comprising a delivery tubearranged about the catheter, and the hemostatic material issubstantially enclosed within the delivery tube.
 37. The method of claim36 additionally comprising advancing the pusher member relative to thedelivery tube so that the pusher member engages the delivery tube,deforms the delivery tube, and deploys hemostatic material from thedelivery tube.
 38. The method of claim 37, wherein the delivery tubecomprises a plurality of elongate tube members, and the tube members areflexible.
 39. The method of claim 38 additionally comprising a collarmember configured to exert an inwardly-directed force on the tubemembers.
 40. The method of claim 39, wherein the collar extendscircumferentially about a portion of the delivery tube.
 41. The methodof claim 38, wherein the delivery tube has a distal end, andadditionally comprising advancing the vessel wound closure device towardthe puncture prior to advancing the pusher member relative to thedelivery tube, and advancing the pusher member relative to the deliverytube when the distal end of the delivery tube is between about 0.5 cmand 1.5 cm from the puncture.